Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— FORWARD  

Official title:

Randomized, Prospective, Placebo-controlled, Multi-center Study to Test the Efficacy of n-3 PUFA for the Maintenance of Normal Sinus Rhythm in Patients With Persistent Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00597220
• Other study ID #: FORWARD
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 8, 2008
• Last updated: June 21, 2011
• Start date: January 2008
• Est. completion date: August 2011

Study information

• Verified date: June 2011
• Source: Fundacion GESICA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

To demonstrate that in patients with persistent atrial fibrillation who had recovered normal sinus rhythm and treated with the best recommended therapies, the addition of 1 gram / daily of n-3 PUFA is superior to the corresponding placebo for the maintenance of normal sinus rhythm at one year of follow up.

Description:

Atrial fibrillation (AF) impose a substantial and growing economic burden on health care expenditures. In patients with persistent AF, there are fundamentally two ways to manage the arrhythmia: to restore and maintain sinus rhythm (rhythm control) or to allow AF to continue and ensure that the ventricular rate is controlled (rate control). As it has been stated, it goes without saying that if we could prevent atrial fibrillation (AF) or restore and maintain sinus rhythm in patients suffering from persistent AF, without any penalties due to the unwanted effects of drugs or incomplete suppression of AF and its thromboembolic complications, every physician would do so. Current strategies however, are limited to achieve such desirable goal. In the last years a growing amount of evidence and attention regarding the cardio-protective role of Omega 3 fatty acids (n-3 PUFA) became progressively clear and appealing.

Epidemiological studies and randomized controlled trials confirms the role of n-3 PUFA in reducing all cause mortality and cardiovascular events mostly in patients at high cardiovascular risk. These effects seems to be mediated mostly by an anti-arrhythmogenic effect.

Basic science confirms and extended clinical observations regarding the antiarrhythmogenic effect of these compounds. Recently both basic research and clinical science suggested a role of n-3 PUFA for the prevention and treatment of supraventricular arrhythmias, particularly AF.

The purpose of the study is to show that the addition of n-3 PUFA on the top of the best recommended therapies can improve the maintenance of normal sinus rhythm in patients with persistent atrial fibrillation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Persistent atrial fibrillation

Exclusion Criteria:

• Contraindications or known hypersensitivity to n-3 PUFA

• Current treatment with n-3 PUFA for any reason

• Heart failure NYHA class IV

• Coronary artery bypass surgery or valve replacement within the past 3 months

• Planned cardiac procedures

• Known sick-sinus syndrome

• Diagnosis of Wolff-Parkinson-White

• Clinical significant valvular etiologies

• Presence of arrhythmia associated with an acute reversible condition

• Advanced chronic lung disease

• Contraindications for anticoagulation therapy

• Pregnancy or lactation

• Any non cardiac illness associated with a life expectancy of < 2 years

• Treatment with any investigational agent within 3 month before randomization

• Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety or be associated with poor adherence to the protocol

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Dietary Supplement:
• Omega 3 (n-3 PUFA)
1 gram of n-3 PUFA containing DHA and EPA

Drug:
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Clinica Constituyentes	Caba	Buenos Aires
Argentina	Complejo Medico Policial Churruca Visca	Caba	Buenos Aires
Argentina	Fundacion Favaloro	Caba	Buenos Aires
Argentina	Hospital Alemán	Caba	Buenos Aires
Argentina	CEMIC (Centro de Educación Médica e Investigaciones Clinicas Norberto Quirno)	Ciudad Autonoma de Buenos Aires
Argentina	Clinica Romagosa	Cordoba
Argentina	Hospital José de San Martín	Corrientes
Argentina	Hospital Evita Pueblo FEDITEC	Lanus	Buenos Aires
Argentina	Clinica y Maternidad Colon	Mar del Plata	Buenos Aires
Argentina	Hospital Privado de la Comunidad	Mar del Plata	Buenos Aires
Argentina	Sanatorio Integral IOT	Misiones
Argentina	Sanatorio Parque	Rosario	Santa Fe
Argentina	Centro Cardiovascular Salta	Salta

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion GESICA

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival free of atrial fibrillation		12 months	Yes
Secondary	Number of patients in sinus rhythm at the time of each study visit		12 months	Yes
Secondary	Number of hospitalizations for CV reasons		12 months	Yes
Secondary	Number of all-cause hospitalizations		12 months	Yes
Secondary	Incidence of TE events		12 months	Yes
Secondary	Number of patients who die or with non-fatal thromboembolic events		12 months	Yes